Visitor Monitoring Drug History: INDOCIN I.V.
 
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Label and Approval History

Drug Name: INDOCIN I.V.
FDA Application No: (NDA) 018878
Active Ingredient(s): INDOMETHACIN SODIUM
Company: OVATION PHARMS
 
Label History
 
View the label approved on January 16, 2007 for INDOCIN I.V., (NDA) 018878


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/12/2007 024Labeling Revision Letter
Label 
2/1/2006 023Labeling Revision Letter
Label 
11/8/2002 020Control Supplement  
5/6/2003 019Labeling Revision Letter 
5/6/2003 018Labeling Revision Letter 
2/12/2001 017Control Supplement  
11/16/2000 016Control Supplement  
10/24/2000 015Control Supplement  
5/15/1998 014Labeling Revision  
10/14/1997 013Manufacturing Change or Addition  
9/13/1994 011Labeling Revision  
9/21/1994 010Labeling Revision  
6/8/1988 005Labeling Revision  
6/20/1985 002Labeling Revision  
10/31/1986 001Manufacturing Change or Addition  
1/30/1985 000Approval  
 
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